PV-10 Intralesional Injection vs Systemic Chemotherapy or Intralesional Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma
The goal of this study is to learn about the effectiveness of PV-10 compared with standard chemotherapy (dacarbazine or temozolomide) or with Imlygic (talimogene laherparepvec) in treating patients with melanoma. The safety and tolerability of PV-10 will also be studied.
Treatment Location: N/A
Primary Objective The primary objective of this study is to assess the effectiveness of intralesional (IL) PV-10 compared to the Investigator’s choice of systemic chemotherapy or intralesional oncolytic viral therapy in treating locally advanced cutaneous melanoma. Effectiveness will be assessed by comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms. Secondary Objectives This study will also include assessment and comparison of the two study treatment arms with respect to: Complete response rate (CRR). Duration of complete response. Overall survival (OS). Safety and tolerability. Exploratory Objectives Change from Baseline domain scores using the Skindex-16 instrument. Change in patient reported lesion pain score from Baseline. Change in patient reported pain medication use from Baseline. Change in Investigator assessed lesion bleeding from Baseline. Change in Investigator assessed lesion ulceration from Baseline. Change in Investigator assessed lesion infection from Baseline.
IRB Review and Approval Date: 04/26/2016
Recruitment Status: Closed
Projected Accrual: N/A